GastroparesisPhase 3NCT01989221
Sancuso® for Gastroparesis: An Open Label Study.
A Phase 3 study testing Sancuso® in people with Gastroparesis, run by Temple University at 1 site in United States.
Trial summary
The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Sancuso®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years of age Diagnosed gastroparesis patients with symptoms of gastroparesis for at least 3 months Symptoms of nausea and vomiting of at least moderate severity using the GCSI Prior history of delayed gastric emptying as determined by scintigraphy Gastroparesis from either diabetic or idiopathic etiologies Symptoms of nausea and vomiting that have not responded adequately to conventional antiemetic agents (Compazine®, Tigan®)
Who cannot join
- Post-surgical gastroparesis Prolonged QTc on EKG Prior intolerance to 5HT3 antagonists (ondansetron or granisetron) Known hypersensitivity to granisetron or to any of the components of the patch Current treatment with ondansetron or granisetron. Patients may stop these medications for one week to enter the study. Patients will not be allowed to take ondansetron or oral granisetron during the study.
- Use of ketoconazole, a medications with known drug-drug interactions with granisetron Women known to be pregnant, as determined on enrollment by a urine pregnancy test Women of childbearing potential who do not agree to use a medically approved form of contraception Nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Sancuso® in Patients With Nausea and/or Vomiting From Gastroparesis: An Open Label Study.
The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with gastroparesis. This will be a prospective open-label study using Sancuso® to treat symptoms of nausea and/or vomiting in patients diagnosed with gastroparesis. Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting will be enrolled. The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to capture the severity of symptoms, including nausea and vomiting, at baseline for one week. Patients will then be treated with Sancuso®. Patients will continue to fill out the GCSI-DD on a daily basis while undergoing treatment with Sancuso® for two weeks. To determine if Sancuso® treatment helps improve symptoms of nausea and vomiting, the symptoms at baseline will be compared to symptoms after the first week and the second week of treatment. Thirty patients diagnosed with gastroparesis (approximately 15 with diabetic and 15 with idiopathic gastroparesis) will be treated on an open label basis with Sancuso®. The goal of this study is to demonstrate the efficacy of Sancuso® in treating nausea and/or vomiting in gastroparesis patients. Safety information will also be collected regarding any adverse effects. If the results are encouraging, as we expect them to be based on personal experience, a larger double blind study would be appropriate.
Read the detailed description
Objectives The aim of this study is determine the efficacy of Sancuso® in improving symptoms of nausea and vomiting in patients with gastroparesis.
The specific objectives of this study are to determine:
- Determine the treatment response of Sancuso® in gastroparetic patients with nausea and/or vomiting.
- Determine which specific symptoms of gastroparesis improve - nausea, vomiting, early satiety, abdominal distension, abdominal pain
- To determine symptomatic responses in both diabetic and idiopathic gastroparesis
- To determine the time course of symptom improvement (with Sancuso® for symptoms of gastroparesis;
The hypotheses to be tested include:
- Sancuso® improves symptoms of gastroparesis.
- Symptoms of nausea and vomiting improve to a greater degree than abdominal pain.
- The beneficial response of Sancuso® is seen in both diabetic and idiopathic gastroparesis.
- The symptom reduction occurs on days 3 after starting treatment and continues throughout the treatment course.
- Conditions
- Gastroparesis
- Being tested
- Sancuso®
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sancuso®Drug
Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
| Study group | Role | What they receive |
|---|---|---|
| Placebo followed by Sancuso | Other | Placebo at baseline for one week followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours for two weeks Receives: Drug: Sancuso® |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCSI-DD Total Composite Symptom Scores.
The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and two weeks of treatment with GTS. The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms. Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day. A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.
Measured: Three weeks
Secondary outcomes (1)
Total Gastrointestinal Nausea and Vomiting Symptom Index
The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and at two weeks of treatment with GTS. The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms. Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day. A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry P Parkman, MD, Principal investigator, Temple University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989221
- Sponsor's protocol ID
- 21086
- Status last verified
- May 2021
- First submitted
- 14 Nov 2013
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sancuso® in Patients With Nausea and/or Vomiting From Gastroparesis: An Open Label Study.
- ClinicalTrials.gov ID
- NCT01989221
- Acronym / sponsor ID
- 21086
- Conditions
- Gastroparesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 26 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the efficacy of Sancuso® (granisetron transdermal system) 3.1 mg/24 hours in improving symptoms of nausea and vomiting in patients with gastroparesis. This will be a prospective open-label study using Sancuso® to treat symptoms of nausea and/or vomiting in patients diagnosed with gastroparesis. Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting will be enrolled. The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) will be used to capture the severity of symptoms, including nausea and vomiting, at baseline for one week. Patients will then be treated with Sancuso®. Patients will continue to fill out the GCSI-DD on a daily basis while undergoing treatment with Sancuso® for two weeks. To determine if Sancuso® treatment helps improve symptoms of nausea and vomiting, the symptoms at baseline will be compared to symptoms after the first week and the second week of treatment. Thirty patients diagnosed with gastroparesis (approximately 15 with diabetic and 15 with idiopathic gastroparesis) will be treated on an open label basis with Sancuso®. The goal of this study is to demonstrate the efficacy of Sancuso® in treating nausea and/or vomiting in gastroparesis patients. Safety information will also be collected regarding any adverse effects. If the results are encouraging, as we expect them to be based on personal experience, a larger double blind study would be appropriate.
Detailed description
Objectives The aim of this study is determine the efficacy of Sancuso® in improving symptoms of nausea and vomiting in patients with gastroparesis.
The specific objectives of this study are to determine:
- Determine the treatment response of Sancuso® in gastroparetic patients with nausea and/or vomiting.
- Determine which specific symptoms of gastroparesis improve - nausea, vomiting, early satiety, abdominal distension, abdominal pain
- To determine symptomatic responses in both diabetic and idiopathic gastroparesis
- To determine the time course of symptom improvement (with Sancuso® for symptoms of gastroparesis;
The hypotheses to be tested include:
- Sancuso® improves symptoms of gastroparesis.
- Symptoms of nausea and vomiting improve to a greater degree than abdominal pain.
- The beneficial response of Sancuso® is seen in both diabetic and idiopathic gastroparesis.
- The symptom reduction occurs on days 3 after starting treatment and continues throughout the treatment course.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo followed by Sancuso | Other | Drug: Sancuso®Placebo at baseline for one week followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours for two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 65 years of age Diagnosed gastroparesis patients with symptoms of gastroparesis for at least 3 months Symptoms of nausea and vomiting of at least moderate severity using the GCSI Prior history of delayed gastric emptying as determined by scintigraphy Gastroparesis from either diabetic or idiopathic etiologies Symptoms of nausea and vomiting that have not responded adequately to conventional antiemetic agents (Compazine®, Tigan®)
Key exclusion criteria (2 listed)
- Post-surgical gastroparesis Prolonged QTc on EKG Prior intolerance to 5HT3 antagonists (ondansetron or granisetron) Known hypersensitivity to granisetron or to any of the components of the patch Current treatment with ondansetron or granisetron. Patients may stop these medications for one week to enter the study. Patients will not be allowed to take ondansetron or oral granisetron during the study.
- Use of ketoconazole, a medications with known drug-drug interactions with granisetron Women known to be pregnant, as determined on enrollment by a urine pregnancy test Women of childbearing potential who do not agree to use a medically approved form of contraception Nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sancuso®Sancuso® (granisetron transdermal system) 3.1 mg/24 hours | Drug | Placebo followed by Sancuso |
Primary outcome
GCSI-DD Total Composite Symptom Scores.
Time frame: Three weeks
The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and two weeks of treatment with GTS. The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms. Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day. A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.
1 secondary outcome
Total Gastrointestinal Nausea and Vomiting Symptom Index
Time frame: Three weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Recruiting
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Gastroparesis Nondiabetic
Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Diabetes, Gastroparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry P Parkman, MD principal investigator
Temple University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sancuso® in people with Gastroparesis, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCSI-DD Total Composite Symptom Scores. (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.